FDAHealthAugust 18, 2025
Boston Scientific Corporation — Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
⚠️ Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 18, 2025
Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy. (Preventive Maintenance Kit distributed to Canada only.)
What's affected?
- Product
- Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
- Lot code
- Batch: 108159110
Additional details
Batch: 108159110
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1 unit.
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